The collaboration agreement grants Takeda an exclusive worldwide license to FIN-524, a synthetic microbiome therapy for IBD, and rights to follow-on products in IBD

Osaka, Japan and Somerville, MA– Finch Therapeutics, a privately held microbiome engineering company, and Takeda Pharmaceutical Company Limited (“Takeda”) (TSE: 4502), today announced a global collaboration agreement to jointly develop FIN-524. FIN-524 is a live biotherapeutic product in pre-clinical research. It is composed of cultured bacterial strains that have been linked to favorable clinical outcomes in studies of microbiota transplantations in IBD. The collaboration combines Finch’s unique discovery platform with Takeda’s strength in drug development for gastrointestinal (GI) diseases to advance a new class of microbial therapy.

“Takeda’s deep GI expertise and recent success in bringing therapies to IBD patients complements our own expertise in microbiome engineering,” said Mark Smith, Ph.D., CEO of Finch. “Our human-first discovery platform uses data from successful clinical experiences with fecal transplants to design novel microbiome therapeutics for IBD and other diseases. Working with Takeda, we’re well positioned to bring a potentially transformative and scalable new therapy to patients.”

“We partner with the most innovative scientists and companies in GI research to speed the discovery and development of new therapeutic options for patients with GI diseases,” said Gareth Hicks, Ph.D., head of gastroenterology drug discovery for Takeda. “The truly innovative approach to therapeutic design established by Finch and the foundation of clinical evidence underlying FIN-524 make us excited to be working with our new partners in this rapidly developing field of medicine.”

Under the terms of the agreement, Takeda will make an upfront payment of $10 million to Finch for the exclusive worldwide rights to develop and commercialize FIN-524 and rights to follow-on products in IBD. Finch will be eligible for development, regulatory and commercial financial milestones and tiered royalties on worldwide net sales. Finch and Takeda may elect to extend this collaboration to additional, related indications on similar terms. Further details of the agreement were not disclosed.

About Finch TherapeuticsFinch Therapeutics is a mission-driven microbiome engineering company that aims to develop novel microbial therapies serving patients with serious and unmet medical needs. Founded by data scientists, clinicians, and microbiologists from MIT and OpenBiome, Finch uses machine learning algorithms informed by high-throughput molecular data to reverse engineer successful experiences with fecal transplantation. Rather than relying on in-vitro screening of a library of isolates, Finch uses this human-first discovery approach to identify strains that drive clinical phenotypes of interest and to develop therapies that deliver these microbial communities to patients. FIN-524, a collection of microbes grown in pure culture to treat IBD, is Finch’s first product candidate based on a synthetic ecology of microorganisms.

Takeda’s Commitment to GastroenterologyTakeda is a global leader in gastroenterology. With expertise spanning more than 25 years, the company’s dedication to innovation continues to evolve and have a lasting impact. Beginning in the 1990’s Takeda pioneered gastroenterological breakthroughs in proton pump inhibitors. Since that time, Takeda’s global capabilities have expanded into the specialty care market in gastroenterology and biologics with a focus on ulcerative colitis and Crohn’s disease. Takeda's expertise also remains focused on therapeutic agents that work to reduce the production of acid in the stomach, and options for the treatment of chronic idiopathic constipation, irritable bowel syndrome with constipation and opioid-induced constipation. Through specialized and strategic in-house development, external partnerships, in-licensing and acquisitions, Takeda currently has a number of promising early stage GI assets in development, and remains committed to delivering innovative, therapeutic options for patients with gastrointestinal and liver diseases.

About Takeda Pharmaceutical CompanyTakeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit www.takeda.com/news.

Takeda’s Forward-Looking StatementsThis press release contains “forward-looking statements.” Forward-looking statements include all statements other than statements of historical fact, including plans, strategies and expectations for the future, statements regarding the expected timing of filings and approvals relating to the transaction, the expected timing of the completion of the transaction, the ability to complete the transaction or to satisfy the various closing conditions, future revenues and profitability from or growth or any assumptions underlying any of the foregoing. Statements made in the future tense, and words such as “anticipate,” “expect,” “project,” “continue,” “believe,” “plan,” “estimate,” “pro forma,” “intend,” “potential,” “target,” “forecast,” “guidance,” “outlook,” “seek,” “assume,” “will,” “may,” “should,” and similar expressions are intended to qualify as forward-looking statements. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors and security holders are cautioned not to place undue reliance on these forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to: required regulatory approvals for the transaction may not be obtained in a timely manner, if at all; the conditions to closing of the transaction may not be satisfied; competitive pressures and developments; applicable laws and regulations; the success or failure of product development programs; actions of regulatory authorities and the timing thereof; changes in exchange rates; and claims or concerns regarding the safety or efficacy of marketed products or product candidates in development.

The forward-looking statements contained in this press release speak only as of the date of this press release, and neither Finch Therapeutics nor Takeda undertake any obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If one or more of these statements is updated or corrected, investors and others should not conclude that additional updates or corrections will be made.

Finch Therapeutics, Inc., a microbiome therapeutics company, and OpenBiome, a leading public stool bank, today announced a collaboration to develop FIN-403, an orally administered microbial therapy for approval by U.S. Food and Drug Administration (FDA) in recurrent C. difficile infections.

London, UK and Somerville, MA - Finch Therapeutics, Inc., a microbiome therapeutics company based in Somerville, MA, and Intract Pharma, an oral drug delivery company based in London, UK, today announced that Finch will use Intract's Phloral® technology to develop a capsule for the targeted delivery of microbial communities into the colon.

Phloral is the world’s only dual-action system for precise and reliable delivery to the large intestine, the predominant site of the gut microbiome. Traditional approaches to colon- targeting rely on a single mechanism to initiate drug release, such as changes in gastrointestinal pH, enzymatic activity, or prolonged transit time. However, given the considerable degree of individual variability in these parameters, these systems often fail, with drug release occurring prematurely, or in many cases, not at all. Phloral combines a pH-responsive polymer and natural polysaccharide as independent but complementary release mechanisms for fail-safe delivery. This cutting-edge technology has demonstrated consistent and clinically proven results in both healthy and diseased states.

“We are thrilled to incorporate a clinically superior and gold-standard gastrointestinal coating technology into our research and development platform,” says Andrew Noh, COO at Finch.

“This long-term partnership between Finch and Intract strengthens our ability to lead the industry in the development of therapeutics for microbiome-mediated diseases.”

“Finch’s innovative discovery platform presents an exciting new frontier in scientific research and represents a significant step in the development of microbial therapeutic products. We are delighted that Phloral will contribute to making these safer, more effective, and better suited to patient needs.” says Bill Lindsay, CEO at Intract.

The Phloral technology will enable the first-in-human discovery approach at Finch. "Phloral is an exciting technology for our research into the microbiome because it enables oral delivery of communities with the same precise targeting as traditional but less convenient colonoscopic delivery,” says Dean Glettig, Director of Product Development at Finch.

About Intract

Intract Pharma is a licensing and product development company offering state-of-art oral drug delivery formulation technologies and specialist gastrointestinal models to develop advanced new therapeutics. Intract is a spin-out from University College London (UCL) and has exclusive licence to oral delivery technologies developed by Professor Abdul Basit of the UCL School of Pharmacy and owned by UCL.

"Finch Therapeutics is designing products comprised of pure cultures of microbes that will serve the same purposes of fecal microbiotas transplantation while also being safer and more scalable." -- Forbes